Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments.

Официальное название

Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction of the Anterior Talofibular and Calcaneofibular Ligaments. A Randomized Stratified Clinical Trial.

Обзор

Primary Objective: To clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. The clinical AOFAS scale will be used for assessment. Secondary Objectives: To determine if there are differences in health outcomes and patient-perceived pain using the specific SP-36 scale and verbal numeric rating scale (VNRS). Additionally, to assess differences in postoperative complication rates and time to return to daily life activities between the two surgical techniques. Study Design: Prospective, randomized, controlled clinical trial with two parallel groups stratified by age and functional demand. Condition or Disorder Being Studied: Chronic lateral ankle instability. Study Population and Sample Size: The target population includes subjects diagnosed with chronic lateral ankle instability. The study population consists of patients diagnosed in the Orthopedics consultations at Hospital Infanta Elena who meet the inclusion and exclusion criteria. Based on sample size calculations, a total of 36 patients will be recruited. However, due to the prospective nature and stratification by epidemiological and functional variables, the sample size may be increased to ensure comparable groups in each stratum. Study Timeline and Estimated Completion Date: The study is expected to begin in the third quarter of 2025. Recruitment is estimated to last 24 months, with a follow-up period of 12 months, for a total duration of 3 years, ending in the third quarter of 2028.

Вмешательства

• Процедура Arthroscopic reconstruction surgery
  Arthroscopic reconstruction with allograft, in which a tendon (generally from a tissue bank) is used to reconstruct the ligaments. This technique is performed through small incisions using arthroscopy.
• Процедура Open surgery
  Open surgery consists of the modified Broström-Gould technique, which allows for the reconstruction of damaged ligaments using the patient's own tissues through an incision on the lateral side of the fibula. This technique has shown satisfactory functional results.

Первичные конечные точки

• Clarify whether arthroscopic reconstruction with allograft provides tangible benefits over the modified open Broström-Gould technique, or if both are equivalent in efficacy and safety. [Срок оценки: From surgery to the end of the follow up at 12 months after surgery]

Вторичные конечные точки (4)

• Determine whether there are differences in health outcomes [Срок оценки: From surgery to the end of the follow up at 12 months after surgery]
• Determine whether there are differences in patient-perceived pain [Срок оценки: From surgery to the end of the follow up at 12 months after surgery]
• Determine whether there are differences between both groups in the rate of postoperative complications. [Срок оценки: From surgery to the end of the follow up at 12 months after surgery]
• Determine whether there are differences in time to return to normal life between the two surgical techniques. [Срок оценки: From surgery to the end of the follow up at 12 months after surgery]

Критерии участия

Критерии включения

Mandatory criteria (all must be marked "yes" in a drop-down tab):

• Age >18 years
• Subjective sensation of instability
• Pathological anterior drawer and varus tilt compared to the contralateral side
• Magnetic resonance imaging showing lesion of the anterior talofibular ligament (ATFL)

Specific criteria (must meet at least one, but can meet several, multiple choice option):

• BMI >30
• High athletic demand (regularly participates in pivoting sports)
• Ligamentous hyperlaxity (Beighton score >8)
• First sprain more than 2 years ago
• More than 5 sprains per year
• Subfibular ossicle >1 cm
• MRI with ATFL showing high T2 signal
• MRI showing disruption/absence of ATFL

Критерии исключения

• History of previous ankle surgery
• Tibiotalar osteoarthritis or presence of chondral lesions on magnetic resonance imaging
• Active infections
• Contraindications for surgery
• Pregnancy
• Lactation
• Known allergy to bovine collagen
• Autoimmune connective tissue disease
• Active oncological process

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario Infanta Elena — Valdemoro

Идентификаторы

NCT: NCT07200271 · INEST2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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